The purpose of this study is to look at safety, tolerability, and pharmacodynamic effects (i.e. how the study drug affects your body) of PF-07258669 in older participants ((60 years to \<90 years) including those at risk of malnutrition. The study medicine PF-07258669 is being developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and food intake, which is an important reason for poor nutrition and health results in people with unintended weight loss. This is approximately a 26-week-long study with 9 visits to the study doctor and 4 telehealth visits (ie. visits by phone call). The study will include * Screening period for up to 4 weeks * Pre-treatment period of 2 weeks * Treatment period of 16 weeks : study drug (PF-07258669 or matching placebo) * Follow-up period of 4 weeks The study requires answering questionnaires and use of digital devices at home to measure blood pressure and physical activity. The study team will monitor how each participant is doing during the study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
7
Oral tablet
Oral tablet
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, United States
JEM Research Institute
Atlantis, Florida, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
De La Cruz Research Center, LLC
Miami, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
AA Medical Research Center
Flint, Michigan, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Javara - Nevada Health Centers - Carson City
Carson City, Nevada, United States
Circuit Clinical
Secaucus, New Jersey, United States
Circuit Clinical /North Hudson Community Action Corporation
West New York, New Jersey, United States
...and 4 more locations
Number of Participants With Treatment Emergent Adverse Events
Time frame: Baseline to Week 20
Percent change from baseline in body weight
Time frame: Baseline to Week 16
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